Allergan LAP-BAND

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

A paper published in the November, 2005 edition of Surgery titled “Obese teenagers treated by Lap-Band System: the Italian experience.” lived up to its name and evaluated “results of laparoscopic adjustable gastric banding in obese teenagers” chosen from “the database of the Italian Collaborative Study Group for Lap-Band”, identifying 58 patients.

The authors of this study, L. Angrisani et al., found that “Overall postoperative complications occurred in 6/58 (10.3%). The band was removed in 6/58 (10.3%) patients for gastric erosion (3 patients), psychologic, intolerance (2 patients), and in the remaining patient was converted 2 years after surgery (BMI 31) to gastric bypass or gastric pouch dilatation.”

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

Researchers write “The objectives of surgical therapy in patients with morbid obesity are reduction of body weight, and a positive influence on the obesity-related comorbidity as well the concomitant psychologic and social restrictions of these patients.”

To perform this study, Champault et al. (2006) studies 152 patients who had a gastric banding system implanted between October 1999 and January 2001. After surgery, the team found that “BMI dropped from 44.3 to 29.6 kg/m and all comorbid conditions improved markedly: diabetes melitus resolved in 71% of the patients, hypertension in 33%, and sleep apnea in 90%”, showing that gastric banding was indeed quite effective.

It was also found, however, that “26 patients (17%) had late complications requiring reoperation.” This represents more than a 300% increase in reoperation rates compared to those reported by Allergan, the manufacturer of the ever popular LAP-BAND gastric banding system.

With the publication of papers such as this, demonstrating such a discrepancy between risk rates reported by manufacturers and those determined by independent researchers, a number of LAP-BAND lawsuits were filed.

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

Researchers found that before surgery, mean weight was “137 +/- 30 kg,” and mean body mass index (BMI) was 48.2 +/- 8kg/m2, and that after one year using the gastric banding systems, “weight and BMI were 110 +/- 24 kg and 38.7 +/- 6 kg/m2, respectively.” Clearly, gastric banding is an effective means of weight reduction in obese patients. Further, relating to diabetes, “There was significant improvement in all measures of glucose metabolism” and “Remission of diabetes occurred in 32 patients (64%), and major improvement of glucose control occurred in 13 patients (26%)”.

While the study found “Improvement in diabetes was related to increased insulin sensitivity and beta-cell function” and that “Weight loss was associated with significant improvements in fasting triglyceride level, HDL cholesterol level, hypertension, sleep, depression, appearance evaluation, and health-related quality of life”, the team also found evidence of serious complications associated with the use of gastric banding systems.

“Early complications occurred in 6% of patients (wound infections in 4%, respiratory support in 2%), and late complications occurred in 30% of patients (gastric prolapse in 20%, band erosion in 6%, and tubing leaks in 4%). All late complications were successfully revised surgically.”

According to the warning label for LAP-BAND by Allergan, only about 1-2% of patients will suffer band erosion, and only about 8% are expected to suffer gastric prolapse. The rate for tubing leaks is also lower according to Allergan.

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

A 2007 report titled “Benchmarking hospital outcomes for laparoscopic adjustable gastric banding.” by MA Edwards et al. published in Surgical Endoscopy set out to review the safety and efficacy of gastric banding systems in obese patients. Gastric banding is a procedure by which an adjustable plastic band is placed around the stomach to make patients feel full after consuming less food.

Researchers studied “87 consecutive patients with a mean age of 43 years” over 24 months, and “conducted a retrospective review of the outcomes including conversion, reoperation, mortality, perforation, erosion, prolapse, port dysfunction, excess weight loss, and changes in comorbidities, then compared the data with published benchmarks.”

Complications surrounding surgery included “acute stoma obstruction” (one patient), and respiratory complications (two patients). “Delayed complications included gastric prolapse” (four patients) “and port reservoir malposition” (also in four patients). Researchers also noted that 5 of 87 bands had to be removed. All of this was seen at the two-year endpoint.

However, it is important to realize that the rates for the above complications are significantly higher than the rates for the same complications reported in the LAP-BAND Warning Label, a popular gastric banding system manufactured by Allergan.

That warning label suggests that about 2.7% of LAP-BANDs will require removal, and the above study suggests the rate is closer to 5.7%. Further, the LAP-BAND Warning Label suggests that only about 1.34% of patients will suffer port problems, while this study found about 4.6% of patients will face that complication.

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

Of these 33 patients who suffered failed gastric banding systems, “29 patients had major re-operation and 4 patients minor re-operation under local anesthesia”. The team writes “The cause of band dysfunction was anterior slippage (n=17), band erosion (n=5), band intolerance (n=3), posterior slippage (n=2) and band leakage (n=2)” and that symptoms of band failure were “vomiting (n=16), pyrosis (n=13), nausea (n=8), retrosternal pain (n=11) and regurgitation (n=5).”

In this series of patients, 19 could have their bands replaced laparoscopically, while “in 3 patients, the laparoscopic procedure was converted to open surgery” and “5 patients underwent conversion to a bypass procedure”. Thankfully, there were no complications after surgery other than wound infections in two patients. While the body mass indexes of these patients continued to decline after reoperation, “3 patients (9%) again developed anterior slippage and a second laparoscopic re-operation was necessary.”

Sadly, the rate for primary complications associated with LAP-BANDs – a popular brand of laparoscopic adjustable gastric banding system by Allergan, Inc. – is greatly understated in the LAP-BAND Warning Label and as such, a number of LAP-BAND lawsuits were filed.

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

A 2013 study by L. Angrisani et al. published in Surgery for Obesity and Related Diseases aimed to “compare outcomes of patients randomly assigned to undergo LAGB or LRYGB at 10 years.” To be clear, “LAGB” means laparoscopic adjustable gastric banding (with systems such as LAP-BAND by Allergan) and “LRYGB” means laparoscopic Roux-en-Y gastric bypass. Both of these are surgical methods for reducing weight in the morbidly obese. Gastric banding involves the placement of a plastic band around the stomach to make one feel full after eating less, and gastric bypass is a procedure in which part of the small intestine is bypassed so less calories are absorbed from consumed food.

By ten years, eight patients “were lost to follow-up” – five gastric banding and three gastric bypass patients. Researchers found that “Reoperations were required in 9 (40.9%) of 22 LAGB patients” and “6 (28.6%) of the 21 LRYGB patients.” Researchers also found that after the ten years, gastric bypass patients had lost more excess weight than gastric banding patients.

Sadly, the manufacturer of the LAP-BAND gastric banding system has failed time and again to warn users of such a risk for reoperation associated with the use of their devices: the LAP-BAND Warning Label states that about 4.6% of patients will require reoperation. As a result of such a discrepancy, a number of LAP-BAND lawsuits have been filed.

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

In a small study, the results of which published in the July 2006 edition of Archives of Surgery, a team of researchers led by WB Browne set out to determine whether patient outcome was better for super morbidly obese patients using laparoscopic adjustable gastric banding (LAGB) or laparoscopic Roux-en-Y gastric bypass (LRYGB).

Retrospectively studying 106 patients with super morbid obesity who underwent either LAGB or LRYGB between February 2001 and June 2004, and evaluated patients for “demographics, weight loss, percentage of excess weight loss, change in body mass index, early (<30 days) and late (> or =30 days) complications, reoperations, medical comorbidity, and patient satisfaction were studied.”

At follow-up (mean follow-up was just over 16 months), researchers found that “Compared with LRYGB, patients who underwent LAGB experienced a greater incidence of late complications …, reoperations …, less weight loss …, and decreased overall satisfaction”. That is, laparoscopic adjustable gastric banding systems such as the LAP-BAND by Allergan, were found to perform worse than gastric bypass procedures.

Researchers also wrote that “patients who underwent LRYGB had a greater resolution of concomitant diabetes mellitus (P < .05) and sleep apnea (P<.01) compared with the LAGB group. Furthermore, postoperative adjustments to achieve consistent weight loss for LAGB recipients ranged from 1 to 15 manipulations” and “Our single mortality was in the LAGB group.”

Concluding that “In super morbidly obese patients, LAGB is significantly associated with more late complications, reoperations, less weight loss, less reduction of medical comorbidity, and patient dissatisfaction compared with LRYGB” and “Further evaluation of LAGB in this patient population appears warranted”, this paper could be used in a LAP-BAND lawsuit to demonstrate to court that the manufacturers of these products knew, or should have known, the risks associated with their products.

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

For this paper, the team studied 492 gastric bypass patients and 406 gastric banding patients, who underwent the relevant procedures between October 2000 and October 2005. After statistical analysis, it was found that “The percentage of excess weight loss was significantly better for patients who underwent [gastric bypass surgery] at all points of follow-up, except at 5 years.” Generally, the gastric bypass and gastric banding procedures are fairly effective methods of weight loss for the severely obese.

The team also found that “Total complications occurred in 32% of patients who underwent [gastric bypass] and 24% of patients who underwent [gastric banding]”. And, that “[the] 90-day mortality rate was .2% in both groups.” Further, Jan et al. determined that “The reoperation rate was the same (17%) in both groups.”

These findings are important: the manufacturer of the gastric banding system studied, the LAP-BAND, by Allergan, reported in the LAP-BAND Warning Label that only about 4.7% of patients will require reoperation. As this paper found a reoperation rate triple that reported by the company, it may be used as evidence in an Allergan LAP-BAND lawsuit to illustrate to a court that Allergan knew, or should have known, the risks associated with its product.

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

In 2005, a small study, the results of which were published in Journal of Gastrointestinal Surgery, found that LAP-BAND (Allergan) complication rates and reoperation rates were higher than for gastric bypass procedures and higher than the rates disclosed by the manufacturer on the warning label.

Allergan reported that 7 of 149 patients required reoperation, a rate of about 4.7%, while this study (by J.C. Jan, et al.) found that 31 of 154 (20%) of LAP-BAND patients required reoperation.

While gastric bypass and LAP-BAND had similar capacity to reduce excess weight, this study finding excess weight loss at 60% and 57% at three years, respectively, it is clear that these procedures do not come without risk: 18% of gastric bypass patients and 20% of LAP-BAND patients were found to suffer complications according to this study.

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

A 2008 article titled “Laparoscopic adjustable gastric banding in an ambulatory surgery center.” published in Surgery for Obesity and Related Diseases by B.M. Watkins et al. published finding regarding the safety and efficacy of LAP-BAND gastric banding systems in 2,411 patients who were implanted with the system between November 2002 and August 2007. The team reported “changes in mean body mass index (BMI), percentage excess body weight loss (%EBWL), and incidence of complications at 1 year, as well as the slippage rate up to 3 years.”

“The majority of operations were completed in less than 1 hour” and the overwhelming majority were performed as outpatient procedures. After one year, 1,144 patients were available for follow-up examination to determine excess weight loss and changes in body mass index, and it was found that on average patients lost 60% of excess weight after one year and BMI lost about 8.8 points.

However, complications were found to occur in “241 of 2,411 (10%) patients” and one patient died. Further, “Cumulative slippage at 1, 2, and 3 years, respectively, was 0.4%, 2.4%, and 10%. There were 56 (2.3%) port-related problems, and 13 band explantations (0.54%).”

Unfortunately, the manufacturer of LAP-BAND systems, Allergan, underestimates the rate at which these and other risks are associated with their product in the LAP-BAND Warning Label, mainly focusing on the benefits. As a result of this, a number of LAP-BAND lawsuits were filed.

About this Blog

This blog chronicles legal and scientific news relating to personal injuries caused by defective drugs and medical devices. It is published by injury lawyer Justinian C. Lane, an attorney who takes a personal interest in each of his clients’ cases.